Leucine recently announced a $7 million series A Funding round led by strategic investor EcoLab – which will scale its Compliance Cloud platform globally. This funding round also saw participation from all existing investors, including Pravega Ventures, Axilor Ventures, Techstars, and angels.
Pharmaceutical manufacturing is the lynchpin for getting drug innovation to people. The compliance protocols are crucial to ensuring the smooth operation of the industry. They are beset by processes that are not fit for purpose and are hindering their ability to deliver life-saving drugs faster. As paper-based records and legacy systems are hampering the large-scale manufacturing of drugs, 2 out of 3 FDA warnings are for non-compliance related to procedures not being followed appropriately, unclear work instructions of methods, failure to review equipment usage logs, and lack of shared functions between Quality Assurance and production departments. These issues are often missed and go unnoticed because of the conventional paper-based systems in the pharmaceutical industry.
Leucine’s Compliance Cloud is a digital twin of the pharma manufacturing shop floor, bringing real-time performance monitoring, compliance management, and actionable insights to the table. And for pharma manufacturers, utilizing data can mean the difference between a successful batch and a costly recall. What differentiates Leucine from legacy digitization tools is its AI-driven capabilities designed to digitize pharma manufacturing workflows faster and provide proactive insights that enable pharma companies to stay compliant and produce faster and cost-effectively.
The Leucine dashboard offers real-time performance monitoring, compliance management, and actionable insights. And Leucine’s platform could be implemented in eight weeks. This speed of implementation is possible due to the proprietary AI-enabled digital process builder based on Large Language Models (LLMs) that rapidly digitize paper SOPs into execution-ready digital formats.
A batch execution procedure is considered one of the most essential documents in pharma manufacturing. This rapid digitization capability reduces the digitization cycle of a batch record from 6-8 months to 3-5 days.
Leucine is now deployed at over 30 companies in over 300 pharma manufacturing facilities across 10 countries, including the US, India, Brazil, Mexico, UAE, and others. Plus, the company also announced the beta launch of Leucine10x, a groundbreaking AI framework designed to serve as a co-pilot in pharmaceutical manufacturing processes. Leucine10x will transform decision-making in pharma manufacturing, enabling Production and Quality Assurance teams to achieve their organization goals with ease and confidence. Built using proprietary LLM technology, Leucine10x offers an army of AI co-pilots that perform highly specialized tasks such as digitizing paper-based SOPs, which creates a digital twin of the shop floor, collaborating with Production Managers in creating dynamic production plans, thus ensuring on-time batch delivery.
More significant is their ability to speed up Root Cause Analysis (RCA) of deviations in the manufacturing process by quickly analyzing data, including text-based records, logs, and even staff interview transcripts, to identify potential issues or patterns that might not be readily apparent.
This funding round will support Leucine in refining its AI capabilities and making its AI Co-pilot a trusted partner to the production and quality managers on the shop floor and in expanding its reach to more facilities and customers.
KEY QUOTES:
“Paper-based manufacturing records are the industry’s Achilles heel, fueling not only regulatory nightmares but also ballooning production costs and inefficiencies. The legacy solutions are no better, with their extremely long implementation cycles and rigid, siloed applications that leave manufacturers in a lurch.”
“Our models are trained on a wealth of pharma data, which allows the platform to create custom workflows enriched with GxP compliance measures, enabling us to deliver unparalleled value at breakneck speed.”
“We’re just scratching the surface; our vision is to leverage AI and technology to bring safe medicine to patients across the world”
— Vivek Gera, founder, and CEO of Leucine
“We’re excited to share that Leucine10x is already operational in select customer facilities under a trusted tester agreement. The response has been incredibly positive, and due to high demand, we’re currently enrolling new customers through a waitlist.”
— Mustaq Singh Bijral, Co-founder and CPO of Leucine
“Vivek and Mustaq have been relentless in their mission to make pharma manufacturing safer. This latest funding round will enable Leucine to bring the power of LLMs and associated technologies to make significant advances in pharma manufacturing. We couldn’t be happier to support them in this quest.”
— Rohit Jain, Co-founder and Partner at Pravega Ventures. Pravega Ventures also invested in the Seed round of Leucine
